MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH HYDROSET/10CC INJECTBLE CEMENT; METHYL METHACRYLATE FOR CRANIOPLASTY

Catalog Number	79-43910
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	02/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received, it will be reported on a supplemental report.
Event or Problem Description
It was reported that the product worked as intended during the case; however, the patient with cement implant experienced convulsions afterward.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Additional information: h6.Correction: d2a.The reported convulsions occurred following implantation; however, the product was reported to have functioned as intended during the procedure.Investigation and medical assessment identified multiple potential causes of postoperative convulsions unrelated to the device.Review of the ifu confirmed relevant contraindications and patient considerations.Based on the available information, no evidence was identified that the device caused or contributed to the reported event.Based on the investigation, there is no indication for an incorrectly working product or any design, material, or manufacturing related issue.Therefore, no corrective and/or preventive actions are deemed necessary at this time.

• Brand Name: HYDROSET/10CC INJECTBLE CEMENT
• Common Device Name: METHYL METHACRYLATE FOR CRANIOPLASTY
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): Stryker Orthopaedics-Mahwah; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: elena gehring ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; +49()7614888208
• MDR Report Key: 24454833
• Report Number: 0008010177-2026-00017
• Device Sequence Number: 10148564
• Product Code: GXP
• UDI-Device Identifier: 07613154275014
• UDI-Public: 07613154275014
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 79-43910
• Device Lot Number: 555S7IC03900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown